Trial Outcomes & Findings for Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi (NCT NCT00634049)
NCT ID: NCT00634049
Last Updated: 2024-12-11
Results Overview
The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
149 participants
Primary outcome timeframe
Day 42, 84 and End of Treatment (EOT [Day 180])
Results posted on
2024-12-11
Participant Flow
Consenting adult participants with proven, probable or possible invasive aspergillosis and renally impaired (RI) or of participants with invasive fungal disease (IFD) caused by rare moulds, yeasts or dimorphic fungi meeting the inclusion and none of the exclusion criteria were considered for entry into the study.
Analysis and interpretation of the results was pathogen dependent and each pathogen was quite rare, therefore it was not feasible to enroll a sufficient number of participants in a randomized controlled trial to power the study adequately to allow statistical comparisons.
Participant milestones
| Measure |
Isavuconazole
Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) \[or per os (PO)\] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
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|---|---|
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Overall Study
STARTED
|
149
|
|
Overall Study
COMPLETED
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146
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Isavuconazole
Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) \[or per os (PO)\] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
|
|---|---|
|
Overall Study
Never received study drug
|
1
|
|
Overall Study
Died prior to receiving study drug
|
1
|
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Overall Study
Screening failure
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1
|
Baseline Characteristics
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Baseline characteristics by cohort
| Measure |
Isavuconazole
n=146 Participants
Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) \[or per os (PO)\] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
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|---|---|
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Age, Continuous
|
49.9 years
STANDARD_DEVIATION 16.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
124 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
20 participants
n=5 Participants
|
|
Region of Enrollment
India
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Lebanon
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
|
Therapy status
Primary Therapy
|
93 participants
n=5 Participants
|
|
Therapy status
Refractory
|
38 participants
n=5 Participants
|
|
Therapy status
Intolerant
|
12 participants
n=5 Participants
|
|
Therapy status
Missing
|
3 participants
n=5 Participants
|
|
Hematologic malignancy
Yes
|
63 participants
n=5 Participants
|
|
Hematologic malignancy
No
|
83 participants
n=5 Participants
|
|
Allogeneic Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT)
Yes
|
26 participants
n=5 Participants
|
|
Allogeneic Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT)
No
|
120 participants
n=5 Participants
|
|
Uncontrolled malignancy
Yes
|
46 participants
n=5 Participants
|
|
Uncontrolled malignancy
No
|
100 participants
n=5 Participants
|
|
Neutropenic
Yes
|
38 participants
n=5 Participants
|
|
Neutropenic
No
|
66 participants
n=5 Participants
|
|
Neutropenic
Missing
|
42 participants
n=5 Participants
|
|
Corticosteroid use
Yes
|
35 participants
n=5 Participants
|
|
Corticosteroid use
No
|
111 participants
n=5 Participants
|
|
T-cell immunosuppressant use
Yes
|
61 participants
n=5 Participants
|
|
T-cell immunosuppressant use
No
|
48 participants
n=5 Participants
|
|
T-cell immunosuppressant use
Missing
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])Population: Modified Intent-To-Treat population (mITT)
The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=20 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=4 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
n=21 Participants
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
n=11 Participants
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
n=5 Participants
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
n=17 Participants
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
n=7 Participants
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
n=29 Participants
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
n=11 Participants
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
n=15 Participants
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
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|---|---|---|---|---|---|---|---|---|---|---|
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Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
Day 84 - Success Rate
|
30.0 percentage of participants
|
25.0 percentage of participants
|
9.5 percentage of participants
|
36.4 percentage of participants
|
20.0 percentage of participants
|
41.2 percentage of participants
|
28.6 percentage of participants
|
44.8 percentage of participants
|
36.4 percentage of participants
|
13.3 percentage of participants
|
|
Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
Day 42- Success Rate
|
25.0 percentage of participants
|
50.0 percentage of participants
|
14.3 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
47.1 percentage of participants
|
28.6 percentage of participants
|
41.4 percentage of participants
|
36.4 percentage of participants
|
13.3 percentage of participants
|
|
Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
End of Treatment (EOT) - Success Rate
|
30.0 percentage of participants
|
66.7 percentage of participants
|
31.6 percentage of participants
|
36.4 percentage of participants
|
20.0 percentage of participants
|
64.7 percentage of participants
|
28.6 percentage of participants
|
64.3 percentage of participants
|
72.7 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])Population: Modified Intent-To-Treat population (mITT)
The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success \[Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=20 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=4 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
n=21 Participants
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
n=11 Participants
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
n=5 Participants
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
n=17 Participants
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
n=7 Participants
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
n=29 Participants
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
n=11 Participants
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
n=15 Participants
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 42- Success Rate
|
55.0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
68.8 percentage of participants
|
71.4 percentage of participants
|
79.3 percentage of participants
|
70.0 percentage of participants
|
42.9 percentage of participants
|
|
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 84 - Success Rate
|
45.0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
42.9 percentage of participants
|
82.8 percentage of participants
|
70.0 percentage of participants
|
35.7 percentage of participants
|
|
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
End of Treatment (EOT) - Success Rate
|
55.0 percentage of participants
|
66.7 percentage of participants
|
55.6 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
81.3 percentage of participants
|
85.7 percentage of participants
|
82.1 percentage of participants
|
70.0 percentage of participants
|
38.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])Population: Modified Intent-To-Treat population (mITT)
The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success \[Eradication and Presumed eradication\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=20 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=4 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
n=21 Participants
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
n=11 Participants
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
n=5 Participants
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
n=17 Participants
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
n=7 Participants
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
n=29 Participants
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
n=11 Participants
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
n=15 Participants
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 42- Success Rate
|
30.0 percentage of participants
|
50.0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
29.4 percentage of participants
|
28.6 percentage of participants
|
27.6 percentage of participants
|
45.5 percentage of participants
|
13.3 percentage of participants
|
|
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 84 - Success Rate
|
35.0 percentage of participants
|
25.0 percentage of participants
|
9.5 percentage of participants
|
27.3 percentage of participants
|
40.0 percentage of participants
|
35.3 percentage of participants
|
28.6 percentage of participants
|
27.6 percentage of participants
|
45.5 percentage of participants
|
13.3 percentage of participants
|
|
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
End of Treatment (EOT) - Success Rate
|
35.0 percentage of participants
|
66.7 percentage of participants
|
31.6 percentage of participants
|
36.4 percentage of participants
|
40.0 percentage of participants
|
70.6 percentage of participants
|
28.6 percentage of participants
|
53.6 percentage of participants
|
81.8 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])Population: Modified Intent-To-Treat population (mITT)
The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success \[Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections\], \[Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections\]; and \[Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=20 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=4 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
n=21 Participants
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
n=11 Participants
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
n=5 Participants
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
n=17 Participants
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
n=7 Participants
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
n=29 Participants
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
n=11 Participants
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
n=15 Participants
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 42- Success Rate
|
30.0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
21.4 percentage of participants
|
0 percentage of participants
|
7.1 percentage of participants
|
|
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
Day 84 - Success Rate
|
20.0 percentage of participants
|
25.0 percentage of participants
|
4.8 percentage of participants
|
20.0 percentage of participants
|
20.0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
28.6 percentage of participants
|
10.0 percentage of participants
|
14.3 percentage of participants
|
|
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
End of Treatment (EOT) - Success Rate
|
15.0 percentage of participants
|
66.7 percentage of participants
|
16.7 percentage of participants
|
20.0 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
10.0 percentage of participants
|
7.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and End of Treatment (EOT [Day 180])Population: Modified Intent-To-Treat population (mITT)
The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success \[Resolution of all attributable clinical symptoms and physical findings\] and \[Resolution of some attributable clinical symptoms and physical findings\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=20 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=4 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
n=21 Participants
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
n=11 Participants
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
n=5 Participants
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
n=17 Participants
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
n=7 Participants
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
n=29 Participants
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
n=11 Participants
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
n=15 Participants
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 42
|
60.0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
28.6 percentage of participants
|
25.0 percentage of participants
|
81.3 percentage of participants
|
85.7 percentage of participants
|
75.9 percentage of participants
|
70.0 percentage of participants
|
50.0 percentage of participants
|
|
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 84
|
55.0 percentage of participants
|
55.0 percentage of participants
|
21.4 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
62.5 percentage of participants
|
42.9 percentage of participants
|
82.2 percentage of participants
|
70.0 percentage of participants
|
35.7 percentage of participants
|
|
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
End of Treatment (EOT)
|
60.0 percentage of participants
|
75.0 percentage of participants
|
42.9 percentage of participants
|
28.6 percentage of participants
|
66.7 percentage of participants
|
81.3 percentage of participants
|
71.4 percentage of participants
|
79.3 percentage of participants
|
70.0 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and End of Treatment (EOT [Day 180])Population: Modified Intent-To-Treat population (mITT)
The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success \[Eradication,Presumed eradication\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=20 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=4 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
n=21 Participants
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
n=11 Participants
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
n=2 Participants
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
n=17 Participants
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
n=7 Participants
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
n=29 Participants
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
n=11 Participants
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
n=15 Participants
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 42
|
46.7 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
28.6 percentage of participants
|
25.0 percentage of participants
|
69.2 percentage of participants
|
83.3 percentage of participants
|
70.6 percentage of participants
|
50.0 percentage of participants
|
18.2 percentage of participants
|
|
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 84
|
44.4 percentage of participants
|
50.0 percentage of participants
|
21.4 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
64.3 percentage of participants
|
42.9 percentage of participants
|
80.0 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
|
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
End of Treatment (EOT)
|
50.0 percentage of participants
|
66.7 percentage of participants
|
42.9 percentage of participants
|
28.6 percentage of participants
|
66.7 percentage of participants
|
78.6 percentage of participants
|
66.7 percentage of participants
|
76.9 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 42, Day 84 and End of Treatment (EOT [Day 180])Population: Modified Intent-To-Treat population (mITT)
The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success \[≥ 90% improvement,≥ 50% to \< 90% improvement and ≥ 25% to \< 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=20 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=4 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
n=21 Participants
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
n=11 Participants
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
n=5 Participants
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
n=17 Participants
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
n=7 Participants
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
n=29 Participants
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
n=11 Participants
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
n=15 Participants
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 84
|
40.0 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
11.1 percentage of participants
|
40.0 percentage of participants
|
40.0 percentage of participants
|
20.0 percentage of participants
|
37.0 percentage of participants
|
0 percentage of participants
|
7.1 percentage of participants
|
|
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
End of Treatment (EOT)
|
35.0 percentage of participants
|
50.0 percentage of participants
|
30.0 percentage of participants
|
22.2 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
40.0 percentage of participants
|
55.6 percentage of participants
|
10.0 percentage of participants
|
14.3 percentage of participants
|
|
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
Day 42
|
35.0 percentage of participants
|
75.0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
46.7 percentage of participants
|
20.0 percentage of participants
|
32.1 percentage of participants
|
9.1 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (EOT [Day 180])Population: Intent-To-Treat population (ITT)
All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=59 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
n=87 Participants
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
All-cause Mortality Through Day 42 and Day 84
All-cause Mortality Through Day 42
|
22.0 percentage of participants
|
16.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
All-cause Mortality Through Day 42 and Day 84
All-cause Mortality Through Day 84
|
30.5 percentage of participants
|
20.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first study drug administration until 28 days after the last dose of study drugPopulation: The safety analysis set (SAF) consists of all enrolled participants who received at least one dose of study drug as this was a non-comparative open-label study
A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.
Outcome measures
| Measure |
mITT - Aspergillus [Renally Impaired]
n=146 Participants
Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) \< 60 mL/min/1.73 m\^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
|
mITT - Aspergillus [Not Renally Impaired]
Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
|
mITT - Mucorales (Primary Therapy)
Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
|
mITT - Mucorales (Refractory)
Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
|
mITT - Mucorales (Intolerant)
Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
|
mITT- Other Filamentous Fungi
Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
|
mITT- Other Mould Species Only
Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
|
mITT- Other Dimorphic Fungi
Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
|
mITT- Other Non-Candida Yeast
Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
|
mITT-Other Mixed Infection
Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety - Overall Number of TEAEs
TEAEs
|
139 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
Study Drug-Related TEAEs
|
60 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
Serious TEAEs
|
89 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
Study Drug-Related Serious TEAEs
|
13 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
TEAEs Leading to Permanent Discontinuation of Stud
|
19 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
Study Drug TEAEs Leading to Perm Discontinuation
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
TEAEs Leading to Death
|
44 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
Study Drug-Related TEAEs Leading to Death
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
Deaths
|
47 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety - Overall Number of TEAEs
Deaths Through 28 Days after Last Dose Study Drug
|
42 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Renally Impaired (RI)
Serious events: 43 serious events
Other events: 54 other events
Deaths: 0 deaths
Not Renally Impaired (NRI)
Serious events: 46 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Renally Impaired (RI)
n=59 participants at risk
Renal impairment was defined as yes for participants who have a baseline as eGFR \< 60 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) formula.
|
Not Renally Impaired (NRI)
n=87 participants at risk
Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) formula.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Atrioventricular block complete
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Electromechanical dissociation
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Eye disorders
Retinal haemorrhage
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Eye disorders
Vitreous haemorrhage
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
3.4%
3/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
4.6%
4/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Death
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
General physical health deterioration
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Multi-organ failure
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Oedema peripheral
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Pyrexia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Hepatobiliary disorders
Cholangiolitis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Immune system disorders
Acute graft versus host disease
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Immune system disorders
Graft versus host disease
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Immune system disorders
Lung transplant rejection
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Aspergillosis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
BK virus infection
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Bacteraemia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Bacterial sepsis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Brain abscess
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Bronchiolitis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Cytomegalovirus enteritis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Empyema
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Escherichia sepsis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Fungal sepsis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Gastroenteritis norovirus
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Influenza
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Lung infection
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Lung infection pseudomonal
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
6.9%
6/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pneumonia bacterial
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pneumonia blastomyces
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pneumonia influenzal
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pneumonia primary atypical
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Pseudomonas bronchitis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Sepsis
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Septic shock
|
10.2%
6/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Urosepsis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Viral diarrhoea
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Zygomycosis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Aphasia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Cerebral infarction
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Headache
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Hemiparesis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Psychiatric disorders
Abnormal behaviour
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Psychiatric disorders
Aggression
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Psychiatric disorders
Agitation
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Psychiatric disorders
Hallucination
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Renal and urinary disorders
Renal failure acute
|
10.2%
6/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
3.4%
3/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Vascular disorders
Arteritis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Vascular disorders
Hypotension
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic infiltration
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
Other adverse events
| Measure |
Renally Impaired (RI)
n=59 participants at risk
Renal impairment was defined as yes for participants who have a baseline as eGFR \< 60 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) formula.
|
Not Renally Impaired (NRI)
n=87 participants at risk
Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) formula.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.2%
6/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Atrial fibrillation
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Sinus tachycardia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Cardiac disorders
Tachycardia
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
4.6%
4/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.9%
7/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
4.6%
4/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
5.7%
5/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Constipation
|
8.5%
5/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
11.5%
10/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.1%
16/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
11.5%
10/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Haematochezia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Nausea
|
32.2%
19/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
16.1%
14/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Gastrointestinal disorders
Vomiting
|
27.1%
16/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
19.5%
17/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Asthenia
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
8.0%
7/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Chills
|
8.5%
5/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
3.4%
3/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Fatigue
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Oedema peripheral
|
13.6%
8/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
9.2%
8/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Pain
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
General disorders
Pyrexia
|
15.3%
9/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
17.2%
15/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Clostridial infection
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Clostridium difficile colitis
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Herpes zoster
|
1.7%
1/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
5.7%
5/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
5/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
6.9%
6/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Infections and infestations
Urinary tract infection
|
11.9%
7/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
6.9%
6/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
6.9%
6/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
4.6%
4/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.9%
7/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
4.6%
4/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
3.4%
3/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.2%
6/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
6.9%
6/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
8.0%
7/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.2%
6/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
9.2%
8/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
5.7%
5/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
3.4%
3/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Dizziness
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
5.7%
5/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Nervous system disorders
Headache
|
18.6%
11/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
16.1%
14/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Psychiatric disorders
Confusional state
|
11.9%
7/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Psychiatric disorders
Insomnia
|
8.5%
5/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
9.2%
8/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Renal and urinary disorders
Oliguria
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
0.00%
0/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Renal and urinary disorders
Renal impairment
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
13.8%
12/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.2%
6/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
8.0%
7/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
5.7%
5/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
1.1%
1/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
4/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
2.3%
2/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
2/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
8.0%
7/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Vascular disorders
Hypertension
|
5.1%
3/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
5.7%
5/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
|
Vascular disorders
Hypotension
|
8.5%
5/59 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
5.7%
5/87 • From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
The safety analysis set is identical to the intent -to-treat (ITT) population (i.e., all enrolled participants who received at least one dose of study drug) as this was a non-comparative open-label study.
|
Additional Information
Vice President, Medical Head ID/IM/TX
Astellas Pharma Global Development, Inc.
Phone: (224) 205-8800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials , and allow Sponsor sixty (60) days to review and comment on them.
- Publication restrictions are in place
Restriction type: OTHER